Manager, Regulatory Affairs Strategy - Immunology & Inflammation

The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. A typical day might include the following: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure Assist in coordination and preparation for Agency meetings and associated briefing document preparation Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings This role might be for you: If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals You bring strong interpersonal skills both written and verbally To be considered for this opportunity We expect you must have an MD, PhD or PharmD degree along with 2+ years of regulatory experience. We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities. Benefits Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Equal Opportunity Statement Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Salary Range (annually) $128,600.00 - $210,000.00 #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc